Large bore vascular closure system

Abstract

A large bore extra-vascular closure system comprises an introducer device (20) having a through lumen (23) and a handle (31) comprising an actuator (24), a fluid impermeable occlusion device (1) having a distal end (6), a proximal end (7), a sidewall section (8) comprising a waist section (9) configured for outward inflection upon axial compression of the device, and a through lumen (10), and an injectable filler material. The occlusion device (11) is configured for adjustment from an elongated delivery configuration in which the occlusion device is dimensioned to fit within the lumen (2) of the introducer device (1) and a squat deployed configuration in which the waist section of the occlusion device is expanded radially outwardly. The device comprises a control wire (40) operably connecting the actuator (24) of the introducer device and the distal end (4A, 31) of the occlusion device (1), wherein the actuator is configured upon actuation to pull the control wire proximally to deploy the occlusion device. The occlusion device (1), control wire (40) and injectable filler material are bioresorbable.

1 . A large bore extra-vascular closure system to occlude a large bore tissue tract proximal to a blood vessel, comprising:
 an introducer device ( 20 ) having a through lumen ( 23 ) and a handle ( 31 ) comprising an actuator ( 24 );   a bioresorbable occlusion device ( 1 ) having a distal end ( 4 A,  31 ), a proximal end ( 4 B,  30 ), a sidewall section comprising a waist section configured for outward inflection upon axial compression of the device, and a through lumen ( 6 ), wherein the occlusion device ( 1 ) is configured for adjustment from an elongated delivery configuration in which the occlusion device is dimensioned to fit within the through lumen ( 23 ) of the introducer device ( 20 ) and a squat deployed configuration in which the waist section of the occlusion device is expanded radially outwardly;   a bioresorbable control wire ( 40 ) operably connecting the actuator ( 24 ) of the introducer device and the distal end ( 4 A,  31 ) of the occlusion device ( 1 ), wherein the actuator is configured upon actuation to pull the control wire proximally to deploy the occlusion device; and   an injectable filler material configured for injection into the hollow lumen of the occlusion device when deployed, wherein the injectable filler material is bioresorbable.   
     
     
         2 . A large bore extra-vascular closure system according to  claim 1 , in which the injectable filler material is thermoresponsive. 
     
     
         3 . A large bore extra-vascular closure system according to  claim 1 or 2 , including a syringe device comprising a delivery conduit configured to extend through the through lumen of the introducer device to deliver injectable filler material into the through lumen of the bioresorbable occlusion device when the bioresorbable occlusion device is deployed. 
     
     
         4 . A large bore extra-vascular closure system according to claim  4 , in which the delivery conduit of the syringe device comprises a non-stick coating configured to inhibit the injectable filler material sticking to an inside of the delivery conduit. 
     
     
         5 . A large bore extra-vascular closure system according to  any preceding claim , in which the sidewall section of the bioresorbable occlusion device comprises a plurality of struts providing a sidewall section with an open framework. 
     
     
         6 . A large bore extra-vascular closure system according to  claim 5 , in which the plurality of struts are arranged around a longitudinal axis of the bioresorbable occlusion device. 
     
     
         7 . A large bore extra-vascular closure system according to  any preceding claim , in which the bioresorbable control wire ( 40 ) extends through a proximal aperture ( 33 ) in the proximal end ( 30 ) of the occlusion device ( 1 ) and through a distal aperture ( 34 ) in the distal end ( 31 ) of the occlusion device and comprises an anchor element ( 43 ) that cannot pass through the distal or proximal aperture, and braking element ( 44 ) dimensioned for a friction fit through the distal or proximal aperture. 
     
     
         8 . A large bore extra-vascular closure system according to  claim 7 , including a plurality of braking elements ( 44 ) disposed on and spaced apart along the bioresorbable control wire ( 40 ) intermediate the ends of the occlusion device ( 1 ) when the occlusion device is in the elongated delivery configuration. 
     
     
         9 . A large bore extra-vascular closure system according to  claim 7 or 8 , in which the anchor element ( 43 ) is disposed on the control wire ( 40 ) distally of the distal aperture ( 34 ) or proximally of the proximal aperture ( 33 ) and is dimensioned such that it cannot pass through the distal aperture. 
     
     
         10 . A large bore extra-vascular closure system according to any of  claims 7 to 9 , in which the distal end ( 31 ) of the occlusion device comprises two distal apertures ( 34 ) and the proximal end ( 30 ) of the device comprises two proximal apertures ( 33 ), in which the control wire ( 40 ) extends through a first of the proximal apertures, loops through the distal apertures in the distal end of the device and extends through a second of the proximal apertures. 
     
     
         11 . A large bore extra-vascular closure system according to  any preceding claim , including a plurality of control wires ( 40 ) connecting the actuator ( 24 ) of the introducer device and the distal end ( 4 A,  31 ) of the occlusion device ( 1 ). 
     
     
         12 . A large bore extra-vascular closure system according to  any preceding claim , in which the control wire ( 40 ) is a closed loop. 
     
     
         13 . A large bore extra-vascular closure system according to  any preceding claim , in which the actuator ( 24 ) is a rotor and the control wire ( 40 ) is mounted to the rotor whereby rotation of the rotor effects movement of the control wire relative to the introducer device. 
     
     
         14 . A large bore extra-vascular closure system according to  claim 13 , in which the rotor comprises a graduated scale disposed on a circumference of the rotor indicating a range of large bore sizes. 
     
     
         15 . A large bore extra-vascular closure system according to  any preceding claim , in which the waisted section of the sidewall is formed by an outward inflection zone ( 9 ) disposed intermediate the ends ( 7 ,  8 ) of each elongated strut ( 5 ) configured to allow the strut fold radially outwardly during deployment. 
     
     
         16 . A large bore extra-vascular closure system according to  claim 15 , in which each of the elongated struts ( 5 ) comprises an inward inflection zone disposed at each end ( 7 ,  8 ) of the strut configured to allow an adjacent section of the strut bend radially outwardly during deployment. 
     
     
         17 . A large bore extra-vascular closure system according to  any preceding claim , in which the occlusion device has a length of 4.0 to 12.0 mm in a delivery configuration and a length of 0.5 to 4.0 mm in a deployed configuration and a maximum diameter of 4.0 to 12.0 mm in a delivery configuration and a maximum diameter of 8.0 to 8.7 mm in a deployed configuration. 
     
     
         18 . A large bore extra-vascular closure system according to  any preceding claim , in which the introducer device comprises a distal conduit housing the through lumen and an outer retractable sheath configured for axial adjustment relative to the distal conduit from a delivery configuration in which a distal end of the outer retractable sheath extends distally of the distal end of the distal conduit providing a space for receipt of the occlusion device and a deployment configuration where the outer retractable sheath is retracted distally to expose the occlusion device to the surrounding wall of the tissue tract. 
     
     
         19 . A large bore extra-vascular closure system according to  any preceding claim , in which the introducer device comprises a distal conduit housing the through lumen and one or more control wire lumens to house the or each control wires. 
     
     
         20 . A large bore extra-vascular closure system according to  claim 19 , in which the distal conduit comprises a first control wire lumen for a descending part of each control wire and a second control wire lumen for an ascending part of each control wire. 
     
     
         21 . A large bore extra-vascular closure system according to  claim 19 or 20 , in which introducer device comprises a window to allow access to a control wire lumen allowing the control wires to be cut after the occlusion device has been deployed and anchored. 
     
     
         22 . A large bore extra-vascular closure system according to  any preceding claim , in which the distal end of the occlusion device has a peripheral flange section that extends radially outwardly of a distal end of the sidewall section, wherein the distal end or peripheral flange section comprises a deformable material.